Arsenal Deformity Spinal Fixation System 47127Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00840967124582), received between Feb 25, 2016 and May 7, 2025 — classified as 41 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (30 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A SET SCREW POPPED OFF OF THE S1 PEDICLE SCREW POSTOPERATIVELY. REVISION SURGERY TOOK PLACE TO REMOVE THE HARDWARE.

  Patient problems: Failure of Implant

  MAUDE report 21977585 ↗
• MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT UNDERWENT A POSTERIOR SPINAL PROCEDURE. AT THE TWO-WEEK POSTOPERATIVE VISIT, A RADIOGRAPH IMAGE REVEALED A SET SCREW COMPLETELY DETACHED FROM THE TULIP HEAD. THERE ARE NO PLANS FOR REVISION SURGERY. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT TO ENSURE THE SET SCREW DOES NOT MIGRATE.

  Patient problems: Failure of Implant

  MAUDE report 19234077 ↗
• MalfunctionApr 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A POSTOPERATIVE VISIT, THE SURGEON NOTICED A SET SCREW HAD BACKED OUT OF THE TULIP HEAD. THERE ARE NO PLANS FOR REVISION SURGERY AT THIS TIME. ORIGINAL SURGERY DATE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667435 ↗
• InjuryMay 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT UNDERWENT REVISION SURGERY TO REMOVE A SET SCREW THAT HAD BACKED OUT.

  Patient problems: Failure of Implant

  MAUDE report 14293661 ↗
• InjuryMay 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT L3-S1. AROUND 7 WEEKS POSTOPERATIVELY, A RADIOGRAPH REVEALED A SET SCREW HAD BACKED OUT OF THE S1 SCREW ON THE RIGHT.

  Patient problems: Failure of Implant

  MAUDE report 14293648 ↗
• InjuryMay 11, 2021Loosening of Implant Not Related to Bone-Ingrowth

  THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2020. FOUR (4) MONTHS AFTER THE SURGERY, LOOSENING OF THE L3 RIGHT SET SCREW WAS FOUND. REVISION SURGERY TO REPLACE THE SET SCREW TOOK PLACE ON (B)(6) 2021. DURING THE SURGERY, L4/L5 SCREW WERE ALSO FOUND LOOSENED AND THE SURGEON RE-TIGHTENED THEM.

  Patient problems: Insufficient Information

  MAUDE report 11809152 ↗
• InjuryMay 11, 2021Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2020 WAS THE INITIAL SURGERY (L3 / L4 / L5 PLIF PROCEDURE). THREE (3) MONTHS AFTER THE SURGERY, THE L5 RIGHT SET SCREW WAS FOUND TO BE LOOSENING. ON (B)(6) 2021 WAS THE REVISION SURGERY TO REPLACE THE SET SCREW. DURING SURGERY, IT WAS FOUND THAT THE L3 AND L4 SET SCREWS WERE ALSO LOOSENING AND THE SURGEON RE-SCREWED THE SETS.

  Patient problems: Insufficient Information

  MAUDE report 11809105 ↗
• InjuryApr 16, 2021Loose or Intermittent Connection; Device Dislodged or Dislocated

  ON (B)(6) 2021 IT WAS FOUND THE SET SCREW IN THE PEDICLE SCREW IMPLANTED AT L4 WAS LOOSENED AND THE ROD CAME OUT OF THE TULIP OF THE SCREW POST SURGERY. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021 TO REMOVE AND REPLACE THE CONSTRUCT. THE ARSENAL SPINAL FIXATION SYSTEM WAS IMPLANTED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 11682737 ↗
• MalfunctionMar 26, 2021Malposition of Device

  POST OP X-RAYS REVEALED THE SET SCREW POSITIONED AT THE L5 HAD BECOME DISENGAGED FROM THE POLYAXIAL SCREW. AT THIS TIME THE PATIENT IS DOING WELL THEREFORE THE SURGEON IS NOT PLANNING ON REVISING.

  Patient problems: Insufficient Information

  MAUDE report 11576410 ↗
• InjuryJul 16, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020 TO REMOVE & REPLACE TWO ARSENAL SET SCREWS. POST-OP IMAGES TAKEN (B)(6) 2020 REVEALED BOTH SET SCREWS LOCATED AT THE L3 HAD BACKED OUT OF POSITION. THE ARSENAL SPINAL FIXATION SYSTEM WAS IMPLANTED ON (B)(6) 2020 AT THE T11-L3.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10283253 ↗
• InjuryJun 30, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  DURING A REVISION SURGERY ON (B)(6) 2020 IT WAS DISCOVERED THAT THE LEFT L5 SET SCREW WAS LOOSE. ADDITIONALLY, THE RIGHT L5 POLYAXIAL SCREW WAS LOOSE IN THE VERTEBRAL BODY; HOWEVER THE SET SCREW ON THIS LEVEL WAS NOT LOOSE. THE PATIENT INFORMED THE SURGEON THAT 6 WEEKS POST-OPERATIVE SURGERY SHE WAS PUSHING A 250 LB. MOTORIZED WHEELCHAIR VERY HARD UP AGAINST A WALL AND FELT A POP IN HER BACK. THIS IS WHEN SHE STARTED TO HAVE BACK PAIN. THE ARSENAL SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2020 AT THE L3-L5.

  Patient problems: Pain

  MAUDE report 10215305 ↗
• InjuryFeb 11, 2020Material Separation

  EXISTING ZODIAC CONSTRUCT OF THE L4-S1 WAS EXTENDED ONE LEVEL (L3) WITH THE ARSENAL FIXATION SYSTEM ON (B)(6) 2019. 1 WEEK FOLLOWING THE FUSION, THE PATIENT HEARD A POP SOUND WHILE STRETCHING HIS BACK. X-RAYS WERE ORDERED FOUND THE LEFT L3 SETSCREW HAD DISASSOCIATED ITSELF FROM THE L3 PEDICLE SCREW. REVISION SURGERY TOOK PLACE ON (B)(6) 2019 TO REMOVE AND REPLACE BOTH THE ARSENAL SET SCREW AND PEDICLE SCREW AT THE L3 WITH THE ZODIAC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9694199 ↗
• InjuryOct 23, 2019Device Dislodged or Dislocated

  REVISION SURGERY WAS CONDUCTED TO REMOVE AN ARSENAL SET SCREW LOCATED AT THE L3. POST-OP X-RAYS TAKEN (B)(6) 2019 REVEALED THE SET SCREW HAD BACKED OUT OF POSITION. THE ARSENAL SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9224430 ↗
• InjuryAug 6, 2019Loose or Intermittent Connection; Device Dislodged or Dislocated

  POST OP X-RAYS TAKEN (B)(6) 2019 REVEALED TWO SET SCREWS HAD LOOSENED AND DISLODGED FROM BOTH POLYAXIAL SCREWS. THE ARSENAL CONSTRUCT WAS IMPLANTED ON (B)(6) 2019 DURING A REVISION SURGERY FOR THE SAME TYPE OF OCCURRENCE (REF. MDR 2027467-2019-00022).

  Patient problems: Failure of Implant

  MAUDE report 8864367 ↗
• InjuryAug 2, 2019Device Dislodged or Dislocated

  POST-OP X-RAYS REVEALED TWO ARSENAL SET SCREWS HAD BACKED OUT OF POSITION. REVISION SURGERY WAS CONDUCTED ON (B)(6) 2019. THE ARSENAL SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8856739 ↗
• MalfunctionAug 2, 2019Device Dislodged or Dislocated

  ARSENAL SET SCREW BACK OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8856700 ↗
• MalfunctionJul 25, 2019Device Dislodged or Dislocated

  POST OP X-RAYS TAKEN (B)(6) 2019 FOUND MULTIPLE SET SCREWS HAVE BEGUN TO BACK OUT OF POSITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8826828 ↗
• MalfunctionMay 29, 2019Device Dislodged or Dislocated

  POST-OP X-RAYS REVEALED AN ARSENAL SET SCREW HAD BACKED OUT OF POSITION. NO REVISION PLANNED AT THIS TIME. THE ARSENAL SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED APPROXIMATELY (B)(6) 2018.

  Patient problems: Failure of Implant

  MAUDE report 8649956 ↗
• MalfunctionMay 7, 2019Device Slipped

  X-RAYS TAKEN DURING A POST-OP VISIT FOUND THE LATERAL L5 SET SCREW HAD BACKED OUT OF POSITION. PATIENT IS WITHOUT COMPLAINT. NO REVISION IS CURRENTLY PLANNED. THE ARSENAL SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8586996 ↗
• InjuryMay 3, 2019Device Dislodged or Dislocated

  REVISION SURGERY WAS CONDUCTED ON (B)(6) 2019 TO REMOVE AN ARSENAL SET SCREW WHICH HAD BACKED OUT APPROXIMATELY 6 MONTHS POST-OP. THE ARSENAL SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8577967 ↗
• InjuryFeb 12, 2019Device Dislodged or Dislocated

  DURING 8 WEEK POST OP VISIT, A REVIEW OF THE X-RAY FOUND ONE OF THE SET SCREWS HAD BACKED OUT OF POSITION. REVISION SURGERY WAS CONDUCTED ON (B)(6) 2019. THE ARSENAL SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2018 DURING A POSTERIOR LUMBER INTERBODY FUSION (PLIF) OF THE L4-5.

  Patient problems: No Code Available

  MAUDE report 8331338 ↗
• MalfunctionJan 30, 2019Loose or Intermittent Connection; Device Dislodged or Dislocated

  POST-OP X-RAYS TAKEN (B)(6) 2019 REVEALED THAT BOTH THE SET SCREWS LOCATED ON THE RIGHT ILIAC HAD BACKED OUT OF POSITION. LOOSENING OF THE SET SCREWS ENABLED THE DISTAL END OF THE ROD TO DETACH FROM THE TULIP OF THE POLYAXIAL SCREW. THE PATIENT IS DOING FINE. REVISION SURGERY IS NOT NEEDED AT THIS TIME, NOR IS THERE ANY PLAN FOR ADDITIONAL SURGERY AS A RESULT OF THIS EVENT. THE ARSENAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8288965 ↗
• InjuryJan 9, 2019Loose or Intermittent Connection

  CT IMAGES REVEALED MIGRATION OF THE SET SCREWS AT THE DISTAL 4-LEVELS OF THE ARSENAL SPINAL FIXATION CONSTRUCT. DURING THE REVISION CONDUCTED ON (B)(6) 2018, SEVEN OF EIGHT SET SCREWS WERE FOUND TO BE LOOSE. ALL 8 SCREWS AT THE DISTAL END OF THE CONSTRUCT WERE REMOVED AND REPLACED WITH AN ALTERNATIVE SYSTEM. THE REMAINDER OF THE CONSTRUCT DID NOT SHOW ANY INDICATION OF AN ISSUE THEREFORE THE TWO SYSTEMS WERE FASTENED VIA A ROD-ROD CONNECTOR. THE ARSENAL SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED (B)(6) 2017 IN A PATIENT WITH PSEUDO ARTHROSIS.

  Patient problems: No Information

  MAUDE report 8231402 ↗
• InjuryOct 24, 2018Fracture; Device Dislodged or Dislocated

  AFTER SUFFERING FROM A FALL, PATIENT RETURNED FOR A 6 MONTH POST-OP VISIT. FILMS TAKEN AT THE TIME SHOWED THE LOCKING SCREW(S) HAD COME OFF THE TULIP OF THE PEDICLE SCREW. ADDITIONALLY, THE BATTALION INTERBODY ALSO FRACTURED AND BACKED OUT INTO THE FORAMEN. REVISION SURGERY WAS CONDUCTED (B)(6) 2018. THE ARSENAL SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED IN (B)(6) 2017.

  Patient problems: Failure of Implant

  MAUDE report 8000412 ↗
• InjuryOct 22, 2018Device Slipped

  APPROXIMATELY TWO WEEKS AFTER IMPLANTATION, A PATIENT RETURNED COMPLAINING OF PAIN ON THE RIGHT SIDE. X-RAYS TAKEN AT THE TIME IDENTIFIED A BACKED OUT SET SCREW AT THE L5. REVISION SURGERY WAS CONDUCTED ON (B)(6) 2018 TO REMOVE THE HARDWARE LOCATED ON THE RIGHT SIDE. REPLACEMENT WAS NOT INSTALLED. THE PATIENT NO LONGER HAS PAIN/SYMPTOMS. THE ARSENAL SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2018.

  Patient problems: Pain

  MAUDE report 7990517 ↗